VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for VITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[52735598] The investigation concluded that multiple lower than expected myog quality control results were obtained using a single non-vitros quality control level in combination with a vitros 5600 integrated system. The investigation could not determine a definitive assignable cause. A within run vitros tt4 marker precision test, used to assess instrument function, was not performed, therefore the vitros 5600 system could not be entirely ruled out as a contributing factor. Based on historical quality control results, a vitros myog reagent performance issue is not a likely contributor to the event, however the possibility that an unexpected vitros myog reagent performance issue or a pre-analytical sample handling issue contributing to the results could not be entirely ruled out. A definitive assignable cause for the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10


[52735599] The customer observed multiple lower than expected vitros myog results obtained from a single non-vitros biorad quality control fluid processed on a vitros 5600 integrated system. Biorad l5 control results of 110. 773, 107. 156, 116. 864, 114. 667, 113. 300, 115. 402, 115. 048, 109. 252, 111. 79, and 115. 014 ng/ml versus customer established baseline mean 127. 95 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate physician action if it were to occur undetected with patient samples. Ortho has not been made aware of any erroneous vitros myog patient results obtained or reported from the laboratory over the time frame of the event, however, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There was no reported allegation of patient harm as a result of this event. This report is number one of two 3500a forms filed for this event, as two devices were affected. This report corresponds to ortho clinical diagnostics (ortho). Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007111389-2016-00140
MDR Report Key5854541
Date Received2016-08-08
Date of Report2016-08-08
Date of Event2016-07-15
Date Mfgr Received2016-07-17
Device Manufacturer Date2015-09-29
Date Added to Maude2016-08-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JAMES A STEVENS
Manufacturer Street100 INDIGO CREEK DRIVE
Manufacturer CityROCHESTER NY 14626
Manufacturer CountryUS
Manufacturer Postal14626
Manufacturer Phone5854533000
Manufacturer G1ORTHO CLINICAL DIAGNOSTICS
Manufacturer StreetFELINDRE MEADOWS PENCOED
Manufacturer CityBRIDGEND, WALES CF355PZ
Manufacturer CountryUK
Manufacturer Postal CodeCF35 5PZ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVITROS IMMUNODIAGNOSTIC PRODUCTS MYOG REAGENT PACK
Generic NameIN-VITRO DIAGNOSTIC
Product CodeDDR
Date Received2016-08-08
Catalog Number6801042
Lot Number1100
Device Expiration Date2016-08-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORTHO-CLINICAL DIAGNOSTICS
Manufacturer Address100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-08

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